DURA-PATCH MODEL DP-XXX

{0}------------------------------------------------ K980548 MAY | 3 1998 ## 510(k) SUMMARY OF SAFETY AND EFFICACY ## Bridger Biomed Dura-Patch™ | Prepared by: | Bruce G. Ruefer, President | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | February 4, 1998 | | Classification Name: | Dura Substitute; 84GXQ | | Common/Usual Names: | Dura Substitute | | Proprietary Name: | Dura-Patch™ Dura Substitute | | Establishment Reg. No. | 9028940 | | Classification: | Class II | | Performance Standards: | Not Applicable. | | Substantial Equivalence: | The dura substitute manufactured by Bridger Biomed Inc.,<br>and is substantially equivalent to the dura substitute<br>Preclude™ Dura Substitute, manufactured and marketed by<br>W.L. Gore & Associates. | | Product Description<br>& Intended Use: | Dura-Patch™ Dura Substitute is a 100% ePTFE membrane,<br>which is intended to be used as a replacement for dura tissue<br>deficiencies. | | Comparative Technological<br>Characteristics: | Dura-Patch™ Dura Substitute is an inert and biocompatible 100% ePTFE membrane, strong enough to resist tears, supple enough to provide comfort, flexible, and is impermeable to CSF, as is the predicate device. Both devices also have a pore size of approximately 1 micron. | | Safety & Efficacy: | Dura-Patch™ is composed of 100% expanded<br>polytetrafluoroethylene or ePTFE. ePTFE is the most inert<br>polymer known at this time. ePTFE has been found to pass | 4 4 {1}------------------------------------------------ biocompatibility assays including U.S.P. Class VI, carcinogenicity studies, hemocompatibility studies, and others. ePTFE has been proven many times over to be nonreactive to body fluids and tissues making it a material of choice for biomaterial applications. Usage of ePTFE as an implant material is well substantiated with over 4,000,000 long-term ePTFE devices implanted to date. In over 25 years of clinical use, and exposure to virtually all major tissue types, there have been no known adverse reactions to the material. Many configurations of ePTFE devices are marketed including; vascular grafts; soft tissue and cardiovascular patches; suture; pericardial, peritoneal and dura replacement membranes, periodontal implants and facial implant devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of three faces in profile, with flowing lines beneath them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 3 1998 Mr. Bruce G. Ruefer President Bridger Biomed, Incorporated 2430 North 7th Street, Suite 4 Bozeman, Montana 59715 Re: K980548 Trade Name: Dura-Patch Model DP-XXX Regulatory Class: II Product Code: GXQ Dated: February 10, 1998 February 12, 1998 Received: Dear Mr. Ruefer: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with ........... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {3}------------------------------------------------ Page 2 - Mr. Ruefer This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## STATEMENT OF INDICATIONS FOR USE The Bridger Biomed Dura-Patch™ is intended for replacement or repair of the dura. Prescription Use . (Per 21 CFR 801.109) Y biolles